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Luiza Toscano, Carina Costa Cotrim, Rodrigo Jorge, Andre Messias, Rubens C Siqueira; Intravitreal Autologous Bone Marrow Derived Cells in Stargardt disease patients: Results after 3 months follow-up. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):3828. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
To evaluate the effects of a single intravitreal injection of autologous bone marrow derived mononuclear cells containing CD 34+ cells<br /> (ABMSC) in patients with Stargardt macular distrophy.
A prospective, single blind, nonrandomized clinical trial, including 9 Stargardt patients able to perform reliable visual field examination (single, and relatively stable fixation locus). Intravitreal ABMSC injection was performed in the eye with worst visual acuity - study eye (SE), while the contralateral eye served as control (CE). Evaluations included best-corrected visual acuity (BCVA), fluorescein angiography (FA), fundus autofluorescence (AF), microperimetry (MAIA - CenterVue) for fixation stability (BCEA), and macular sensitivity (AVTH) determination. Multifocal electroretinograms (ERG) were performed according to the ISCEV standard using Espion E2 (Diagnosys LLC). Examinations were performed at baseline, 1, 3, 8 and 12 months after injection.
Six patients finished 3 months follow-up, and none showed significant adverse effects. At baseline,mean±SE BCVA was SE:1.04±0.08logMAR, and CE:0.98±0.08logMAR. A slightly higher BCVA improvement was observed at 1 month for SE:0.11±0.05 logMAR than for CE:0.4±0.04 logMAR (P=0.0196), and at 3 months SE:0.15±0.05 logMA; CE:0.05±0.05 logMAR (P=0.0098). AVTH at baseline was SE:15.47±1.93 dB and CE:17.13 ± 1.95 dB, and although a small but significant improvement of 3.99±1.33 dB (P=0.0086) and 5.93±2.02 dB (P=0.0133) was observed for SE at 1 and 3 months respectively, this change was not statistically significant different (P>0.05) to the variation observed for CE: 1.84±1.84 dB (P=0.1728) and 3.56±3.05 dB (P=0.1563) at 1 and 3 months respectively. No significant changes were observed for BCEA,mfERG responses amplitudes and latencies or macular structure assessed with OCT and FA or AF.
These data indicate that intravitreal ABMSC is associated to a small improvement of visual acuity and macular sensitivity thresholds up to 3 months after injection in Stargardt disease. Longer follow-up and a large number of cases are needed to confirm these findings.
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